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Recurrent Inguinal Hernia Treatment - Lichtenstein Versus Laparoscopic Totally Extraperitoneal Preperitoneal Hernioplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00642200
First Posted: March 24, 2008
Last Update Posted: May 22, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Kuopio Computing Center
Information provided by:
North Karelia Central Hospital
  Purpose
The study aims at detecting possible differences between an open (Lichtenstein) and a video-assisted (TEP) technique in treating recurrent inguinal hernia. The differences monitored are further recurrence and chronic pain as well as primary complications.

Condition Intervention
Recurrent Inguinal Hernia Procedure: Lichtenstein hernioplasty Procedure: Laparoscopic TEP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lichtenstein Hernioplasty Versus Totally Extraperitoneal Laparoscopic Hernioplasty in Treatment of Recurrent Inguinal Hernia - A Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by North Karelia Central Hospital:

Primary Outcome Measures:
  • further recurrence [ Time Frame: 3 weeks, 1 year, 2 years, 3 years ]

Secondary Outcome Measures:
  • chronic pain or discomfort [ Time Frame: 3 weeks, 1 year, 2 years, 3 years ]

Enrollment: 100
Study Start Date: January 1997
Study Completion Date: April 2007
Primary Completion Date: February 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Patients receive Lichtenstein hernioplasty as a treatment for recurrent inguinal hernia.
Procedure: Lichtenstein hernioplasty
Active Comparator: 2
Patients receive laparoscopic TEP as a treatment for recurrent inguinal hernia.
Procedure: Laparoscopic TEP

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • recurrent inguinal hernia
  • willing to participate

Exclusion Criteria:

  • unwilling to participate
  • bilateral hernia
  • preference towards either treatment arm
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00642200


Locations
Finland
North Karelia Central Hospital - Clinic of Surgery
Joensuu, North Karelia, Finland, FI-80210
Sponsors and Collaborators
North Karelia Central Hospital
University of Kuopio Computing Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MD Sanna Kouhia, North Karelia Central Hospital, Clinic of Surgery
ClinicalTrials.gov Identifier: NCT00642200     History of Changes
Other Study ID Numbers: NKCH-surg-001
First Submitted: March 18, 2008
First Posted: March 24, 2008
Last Update Posted: May 22, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal